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Session 66 Poster Presentations
New Antiretrovirals
Session Day and Time: Tuesday 1:30 - 3:30 pm
Room: Hall A


551
Once-daily Combination of Emtricitabine, Didanosine, and Efavirenz vs Continued PI-based HAART in HIV-infected Adults with Undetectable Plasma HIV-RNA: 48-week Results of a Prospective Randomized Multicenter Trial (ALIZE-ANRS 99).
J M Molina*1, F Ferchal1, C Rancinan2, P Yeni3, W Rozenbaum4, V Journot2, L Morand-Joubert5, S Fournier1, P Morlat 6, B Dupont 7, JF Delfraissy8, P Dellamonica9, I Poizot-Martin10, E Rosenthal9, G Chene2
1Hosp St Louis, Paris, France; 2INSERM U330, Bordeaux, France; 3Hosp Bichat, Paris, France; 4Hosp Tenon, Paris, France; 5Hosp St Antoine, Paris, France; 6Hosp de Bordeaux, France; 7Hosp Necker, Paris, France; 8Hosp Kremlin Bicetre, Paris, France; 9Hosp de Nice, Paris, France; and 10Hosp de Marseille, France

Background: Simple but potent antiretroviral regimens might enhance convenience and adherence to therapy. Substitution of complicated regimens with a once-daily regimen may provide these benefits.

Methods: In a prospective, open-label, multicenter, non-inferiority study, patients (pts) receiving a PI-based regimen with plasma HIV-RNA level < 400 copies/mL were randomized to continue their regimen (C) or to switch to once-daily combination (5 pills per day) of emtricitabine, didanosine, and efavirenz (OD). Virological failure was defined as a confirmed plasma HIV-RNA ≥ 400 copies/mL and success as no virological failure from baseline to wk 48. Non-inferiority was achieved if the upper limit of the one-tailed 95% confidence interval (ULC) for the difference in proportion of success between M and OD was lower than 15%. Intention-to-treat on available data (ITT), on treatment on available data (OT), and intention-to-treat with missing = failure (M=F) analyses were conducted.

Results: A total 355 pts were randomized; 86% were male with a median age of 41 yrs, a median duration of PI of 35 months (mos), and a median CD4 count of 540 cells/mm3. Proportion of pts with success at 48 wks is shown in the Table below.

Proportion of Patients with Success (%)

Analysis      “Continue” arm Once-daily arm   Difference C-OD   ULC

ITT                         92                       94                         -1.6                      3.0
OT                         93                        96                         -2.8                      1.2
M=F                      88                        89                         -1.8                      3.8

 

Proportion of pts with plasma HIV RNA < 50 copies/mL at wk 48 was significantly higher in the OD than in the C arm (95% versus 87%, p = 0.01). Median CD4 count increase was similar between arms (+13 and +21/mm3 in the C and OD arms, respectively, p = 0.7). Rates of treatment discontinuations were also similar between arms (12.4% and 10.1% in the C and OD arms, respectively, p = 0.5). A significant increase in median fasting HDL cholesterol levels was observed in the OD arm as compared to the C arm (+0.2 vs +0.0 mmol/L, respectively, p < 10-4). Other metabolic parameters remained similar between arms throughout the 48 wks of the study.

Conclusion: The substitution of a PI-based regimen by a simple once-daily combination of emtricitabine, didanosine, and efavirenz maintained full control of plasma HIV-RNA levels and continued increases in CD4 counts for 48 wks.